An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)

Sponsor

Orasis Pharmaceuticals Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04599972

Collaborator

(none)

304

Enrollment

Locations

Arms

15.1

Actual Duration (Months)

16.9

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: CSF-1 Drug: Vehicle	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

304 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-2 Study: Near Eye-vision Acuity Restoration)

Actual Study Start Date :

Oct 26, 2020

Actual Primary Completion Date :

Jan 21, 2022

Actual Study Completion Date :

Jan 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CSF-1 One drop bilaterally twice daily for approximately 2 weeks.	Drug: CSF-1 One drop bilaterally twice daily for approximately 2 weeks.
Placebo Comparator: Vehicle One drop bilaterally twice daily for approximately 2 weeks.	Drug: Vehicle One drop bilaterally twice daily for approximately 2 weeks.

Arm

Intervention/Treatment

Experimental: CSF-1

One drop bilaterally twice daily for approximately 2 weeks.

Drug: CSF-1

One drop bilaterally twice daily for approximately 2 weeks.

Placebo Comparator: Vehicle

One drop bilaterally twice daily for approximately 2 weeks.

Drug: Vehicle

One drop bilaterally twice daily for approximately 2 weeks.

Outcome Measures

Primary Outcome Measures

Percentage of subjects with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m. [Day 8]

Secondary Outcome Measures

Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m. [Day 1/Day 8/Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must have presbyopia.

Exclusion Criteria:

Subjects must not:

Have any contraindications to the study medications or diagnoses that would confound the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orasis Investigative Site	Chandler	Arizona	United States	85225
2	Orasis Investigative Site	Mesa	Arizona	United States	85202
3	Orasis Investigative Site	Phoenix	Arizona	United States	85032
4	Orasis Investigative Site	Garden Grove	California	United States	92843
5	Orasis Investigative Site	Mission Hills	California	United States	91345
6	Orasis Investigative Site	Newport Beach	California	United States	92663
7	Orasis Investigative Site	Petaluma	California	United States	94954
8	Orasis Investigative Site	Littleton	Colorado	United States	80120
9	Orasis Investigative Site	Danbury	Connecticut	United States	06810
10	Orasis Investigative Site	Delray Beach	Florida	United States	33484
11	Orasis Investigative Site	Rock Island	Illinois	United States	61201
12	Orasis Investigative Site	Rochester	New York	United States	14618
13	Orasis Investigative Site	Kingston	Pennsylvania	United States	18704
14	Orasis Investigative Site	Cedar Park	Texas	United States	78613
15	Orasis Investigative Site	San Antonio	Texas	United States	78229
16	Orasis Investigative Site	Clinton	Utah	United States	84015
17	Orasis Investigative Site	Draper	Utah	United States	84020
18	Orasis Investigative Site	Lynchburg	Virginia	United States	24502

Sponsors and Collaborators

Orasis Pharmaceuticals Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Orasis Pharmaceuticals Ltd.

ClinicalTrials.gov Identifier:

NCT04599972

Other Study ID Numbers:

20-150-0003

First Posted:

Oct 23, 2020

Last Update Posted:

Feb 24, 2022

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Presbyopia

Study Results

No Results Posted as of Feb 24, 2022